When Should Medicare Pay for Unproven Use of Cancer Drugs?

The feds recently shifted rules to expand Medicare reimbursement for unapproved uses of cancer drugs, the New York Times and WSJ report this morning.

The latest cancer drugs can cost tens of thousands of dollars per patient. Medicare spends more than $3 billion a year on cancer drugs, and private insurers, who pay for most of the rest of the $45 billion spent on the medicines, typically follow Medicare’s lead, the WSJ writes.

Drugs that have been shown to improve outcomes in one type of cancer may not help patients with other kinds of cancer. At the same time, no one wants to deny options to dying patients, and it can take years to get an FDA approval for a particular tumor type.

Until late last year, Medicare relied on a single compendium, published by the American Hospital Formulary System to guide reimbursements for off-label use of cancer drugs. But a November rule shift expanded reimbursements to cover off-label uses described in four different compendiums.

The new rules are raising questions about conflicts of interest, because at least one of the compendiums, published by the National Comprehensive Cancer Network, includes input from doctors with financial ties to industry. The NCCN itself also receives support from industry. But the group says it manages potential conflicts by disclosing all financial ties, and by making sure panels are big enough to prevent a single researcher from having undue influence, the WSJ says.

The changes are expected to increase off-label uses of several drugs, including Genentech’s Avastin and Eli Lilly’s Gemzar.

Comments (5 of 13)

This creates competition. When several drugs are potentially covered, they have to fight with each other to have the most convincing data.
The idea that cancer patients and oncologists will blindly use the least-effective drug in a group where several are cleared for potential coverage - is laughable.
This is a tempest in a teapot.
It actually promotes data and competition.

8:43 am January 28, 2009

Tom Bruening wrote :

My 54 year old wife has outlived her 2 year death row judgement handed down by a local onconlogist for stage 4 kidney cancer with rare sarcomatoid tumour. Joan is recieving Avastin, Gemzar, xeloda off trial at M.D. Anderson, one of the few (maybe 3) places in the U.S. where it is available. Other National Comprehensive Cancer institutes will not provide this combo for Medicare Patients. Joan has been stable for 16 months on the protocol, paid for by our private Blue Cross Blue Shield policy that we own. This is a free standing not for profit Blue with 800,000 members.

5:32 pm January 27, 2009

Scott S. wrote :

Off-label use of drugs is ABSOLUTELY VITAL in treating cancer. The 'gold standard' in chronic lymphocytic leukemia is FCR, fludarabine, cyclophosphamide and rituximab.

Rituximab has never been approved for use in CLL, yet it is often used, and has given the highest complete remission rates in this incurable cancer. It is used as a single agent, and increasingly in clinical trials in combination with a wide variety of other drugs.

To limit off-label use is to consign thousands of CLL patients, and millions of other cancer patients, to an early death.

Expect it in Obamacare, the socialized medicine scheme to be rammed down our throats in short order.

4:37 pm January 27, 2009

Robert Reinhard, Public Health Consultant wrote :

The expansion of listed compendia is welcome. Physicians act as gatekeepers of when an off label use will be beneficial, this allows them more freedom to base decisions on best medical judgement. It would also be helpful to broaden this debate beyond cancer therapies since many other off label drugs need consideration for other illnesses and infections